Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-12 @ 11:09 PM
Study NCT ID:
NCT06547658
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mouth Closure on Airflow in OSA
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
The Heterogeneous Effects of Mouth Closure on Airflow in Patients With Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, we propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.
Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.
We evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. We also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.
Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.
We evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. We also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL128658 | NIH | None | https://reporter.nih.gov/quic… | View |